FDA Adverse Event
Malfunction
Summary report: N
CLINITEK ATLAS
MDR report key: 2245062
·
Received August 4, 2011
Report
- Report Number
- 1217157-2011-00025
- Event Type
- Malfunction
- Date Received
- August 4, 2011
- Date of Event
- July 5, 2011
- Report Date
- July 5, 2011
- Manufacturer
- SPARTON MEDICAL SYSTEMS
- Product Code
- JHJ
- PMA / PMN Number
- K031947
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
FIELD SERVICE ENGINEER DISPATCHED. INSTRUMENT READ HEAD AND LAMP REPLACED. INSTRUMENT OPERATING ACCORDING TO SPECIFICATION. THE REASON FOR THE INCORRECT RESULT IS NOT KNOWN.
Description of Event or Problem · 1
CUSTOMER REPORTED A NEGATIVE BLOOD RESULT FROM THE INSTRUMENT. UF RESULT FOR RBC WAS 30. MANUAL MICROSCOPIC EXAMINATION INDICATED MANY BLOOD CELLS. NO UNNECESSARY MEDICAL PROCEDURE WAS PERFORMED. NO TREATMENT WAS WITHHELD AS A RESULT OF THIS INCIDENT. THERE WAS NO IMPACT TO PATIENT HEALTH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CLINITEK ATLAS | CLINITEK ATLAS | JHJ | SPARTON MEDICAL SYSTEMS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |